Efficacy and Safety of Injection Sepsivac® (Heat-killed Mycobacterium W) in Gram-negative Sepsis administered via an Intravenous Route.

Abstract

As an immunomodulator, the mycobacterium w (Mw) has improved outcomes for patients suffering from severe sepsis. The traditional route of administration for Mw is intradermal (ID), which is limited to administering 0.1 mL per injection (Inj). The intravenous (IV) route can be an alternative to ID. To evaluate the safety and efficacy of Inj Sepsivac® IV in gram-negative sepsis. Present retrospective observational study was conducted in an intensive care unit (ICU) of tertiary care hospital. The study included 30 consecutive patients with presumed gram-negative sepsis within 48 hours of the first organ dysfunction. Patients received Inj Sepsivac® 0.3 mL diluted in 100 mL normal saline to be given as slow IV infusions over at least 15 minutes, every day for 3 consecutive days. Efficacy was assessed by recording the change in vital parameters, sequential organ failure assessment (SOFA) score, and laboratory investigations. Safety was evaluated by the occurrence of allergic reactions including anaphylaxis, the site of infection, and secondary infection. Each patient was followed up for 14 days from the day of enrolment. Mean age of patients with gram-negative sepsis was 62.67 ± 12.77 years with male preponderance (63.3%). Pneumonia (40.1%) and intraabdominal infections (26.7%) were the most common etiologies of sepsis. A significant improvement in all the vitals and mean SOFA scores was observed from day 2 onward. More than half of the patients required ventilator support [17 (56.7%)], and mortality was observed in 7 (25%) patients. None was reported to have a secondary infection. Laboratory parameters improved and oxygen requirement was reduced postday 4 till the end of treatment from baseline. The IV route of administration was found to be efficacious and safe and allow ease of administration in treating gram-negative sepsis. Further large multicentric randomized trials are required to confirm our findings.